A Phase 3b Study to Evaluate the Safety and Efficacy of Elagolix in Combination With Combined Oral Contraceptives in Premenopausal Women With Documented Endometriosis and Associated Moderate to Severe Pain

Who is this study for? Patients with Endometriosis
What treatments are being studied? Elagolix+Combined Oral Contraceptive (COC)
Status: Recruiting
Location: See all (179) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Endometriosis is a painful disorder of the uterus affecting 6-10% of women of childbearing age. Endometriosis affects daily activities, social relationships, sexuality and sexual activity, and mental health. This study will evaluate how well elagolix in combination with combined oral contraceptives (COC) works within the body and/or how safe it is compared to placebo (does not contain treatment drug). This study will assess the dysmenorrhea (painful periods) response in participants with endometriosis and associated pain. Elagolix is an approved drug for the management of moderate to severe pain associated with endometriosis. Participants are randomly put in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Adult female participants who still have periods with a diagnosis of endometriosis will be enrolled. Around 800 participants will be enrolled in the study at multiple sites in the United States, including Puerto Rico. Participants will receive oral elagolix or placebo tablets in combination with combined oral contraceptive (COC) or placebo capsules for 3 months. All the participants will receive elagolix tablets in combination with COC tablets from Month 4 through Month 18. There will be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 49
Healthy Volunteers: f
View:

• Documented surgical confirmation of endometriosis and associated moderate to severe pain.

• Participants must agree to use dual non-hormonal methods of contraception consistently during washout (if applicable), screening, and 3-month double-blind placebo-controlled treatment periods of the study.

• Participant, in the investigator's opinion must be an appropriate candidate to receive combined oral contraceptives (COCs).

Locations
United States
Alabama
Pinnacle Research Group /ID# 217062
COMPLETED
Anniston
ACCEL Research Sites /ID# 218044
COMPLETED
Birmingham
Alabama Clinical Therapeutics /ID# 217166
COMPLETED
Birmingham
Alabama Clinical Therapeutics /ID# 222301
COMPLETED
Birmingham
University of Alabama at Birmingham - Women's and Infant's Center /ID# 224503
RECRUITING
Birmingham
Trinity Research Group /ID# 246932
RECRUITING
Dothan
Southern Women's Specialists PC /ID# 217143
COMPLETED
Fairhope
Mobile, OBGYN P.C. /ID# 217135
COMPLETED
Mobile
Women's Health Alliance of Mobile /ID# 222591
RECRUITING
Mobile
Arkansas
Applied Research Center of Arkansas /ID# 248494
RECRUITING
Little Rock
Unity Health- Searcy Medical Center /ID# 217050
RECRUITING
Searcy
Arizona
North Valley Women's Care /ID# 217092
RECRUITING
Glendale
MomDoc Womens Health Research /ID# 221661
COMPLETED
Phoenix
California
Diagnamics Inc. /ID# 225385
RECRUITING
Encinitas
Atella Clinical Research /ID# 224024
COMPLETED
La Palma
Valley Renal Medical Group Research /ID# 228614
COMPLETED
Northridge
Futura Research, Org /ID# 217361
COMPLETED
Norwalk
Northern California Research /ID# 217301
COMPLETED
Sacramento
A & B Clinical Research /ID# 224471
COMPLETED
San Diego
Advanced Clinical Research Center, LLC /ID# 248398
COMPLETED
San Diego
Colorado
Rocky Mountain Internal Medicine - Aurora /ID# 245161
COMPLETED
Aurora
Velocity Clinical Research - Denver /ID# 217297
COMPLETED
Denver
Boeson Research - Grand Junction /ID# 248580
COMPLETED
Grand Junction
Advanced Women's Health Institute /ID# 217150
RECRUITING
Greenwood Village
Red Rocks OB/GYN /ID# 217103
COMPLETED
Lakewood
Washington, D.c.
James A. Simon, MD, PC /ID# 218116
RECRUITING
Washington D.c.
Medstar Health Research Institute /ID# 244937
COMPLETED
Washington D.c.
Delaware
Reproductive Assoc of Delaware /ID# 227764
COMPLETED
Newark
Florida
Topaz Clinical Research /ID# 218615
COMPLETED
Apopka
Ideal Clinical Research Inc. /ID# 218832
RECRUITING
Aventura
Helix Biomedics, LLC /ID# 218649
RECRUITING
Boynton Beach
Olympian Clinical Research /ID# 244426
COMPLETED
Clearwater
Women's Medical Research Group /ID# 218524
COMPLETED
Clearwater
Doral Medical Research, LLC /ID# 225146
RECRUITING
Doral
Universal Axon Clinical Research /ID# 248553
COMPLETED
Doral
KO Clinical Research, LLC /ID# 217173
COMPLETED
Fort Lauderdale
Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 217061
COMPLETED
Fort Myers
Care Partners Clinical Research /ID# 217042
COMPLETED
Jacksonville
Solutions Through Adv Rch /ID# 220973
RECRUITING
Jacksonville
Kissimmee Clinical Research /ID# 224749
COMPLETED
Kissimmee
Vida Clinical Research /ID# 245325
COMPLETED
Kissimmee
South Florida Wellness & Clinic /ID# 222897
RECRUITING
Margate
Admed Research LLC /ID# 227679
COMPLETED
Miami
Gold Coast Health Research, LLC /ID# 248624
RECRUITING
Miami
GRE Clinical Research, LLC /ID# 246579
COMPLETED
Miami
Innova Pharma Research /ID# 245354
COMPLETED
Miami
The Miami Research Group Inc /ID# 246578
COMPLETED
Miami
Ocean Blue Medical Research Center, Inc /ID# 217286
COMPLETED
Miami Springs
Salom Tangir, LLC /ID# 217273
COMPLETED
Miramar
Advanced Research Institute, Inc /ID# 217206
RECRUITING
New Port Richey
Suncoast Clinical Research Pasco County /ID# 217249
RECRUITING
New Port Richey
Segal Institute for Clinical Research /ID# 221518
COMPLETED
North Miami
A Premier Medical Research of FL /ID# 216908
COMPLETED
Orange City
Clinical Associates of Orlando /ID# 218114
RECRUITING
Orlando
Omega Research Group /ID# 216907
RECRUITING
Orlando
Osceola Gynecology, LLC - Orlando /ID# 227194
COMPLETED
Orlando
Duplicate_Suncoast Clinical Research - Palm Harbor /ID# 219133
COMPLETED
Palm Harbor
Royal Research,Corp /ID# 221356
RECRUITING
Pembroke Pines
Physician Care Clin. Res., LLC /ID# 217264
RECRUITING
Sarasota
GCP Clinical Research, LLC /ID# 217232
RECRUITING
Tampa
Tampa General Hospital - Tampa - General Circle /ID# 217146
COMPLETED
Tampa
Virtus Research Consultants, LLC /ID# 217052
COMPLETED
Wellington
Florida Premier Research Institute, LLC /ID# 224499
COMPLETED
Winter Park
Georgia
Paramount Research Solutions /ID# 218769
COMPLETED
Alpharetta
Academia of Women's Health & Endoscopic Surgery /ID# 217260
COMPLETED
Atlanta
Atlanta Women's Research Institute /ID# 217303
COMPLETED
Atlanta
Gyn & Fertility Specialists /ID# 223015
COMPLETED
Atlanta
Paramount Research Solutions - College Park /ID# 217358
COMPLETED
College Park
Duplicate_Columbus Regional Research Ins /ID# 217294
COMPLETED
Columbus
Midtown OBGYN North /ID# 222300
RECRUITING
Columbus
Innovative Women's HealthCare Solutions - Smyrna /ID# 223692
COMPLETED
Smyrna
Journey Medical Research Institute - Snellville /ID# 229774
RECRUITING
Snellville
Iowa
University of Iowa Hospitals and Clinics /ID# 217144
COMPLETED
Iowa City
The Iowa Clinic, PC /ID# 217351
RECRUITING
West Des Moines
Idaho
Leavitt Womens Healthcare /ID# 217118
COMPLETED
Idaho Falls
Womens Healthcare Assoc, DBA /ID# 222153
RECRUITING
Idaho Falls
Sonora Clinical Research /ID# 222147
COMPLETED
Meridian
Asr, Llc /Id# 217094
ACTIVE_NOT_RECRUITING
Nampa
Illinois
Women's Health Care Center Of Chicago /ID# 245164
COMPLETED
Chicago
Alliance for Multispecialty Research, LLC /ID# 217226
COMPLETED
Oak Brook
The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 245372
COMPLETED
Park Ridge
Indiana
American Health Network of IN, LLC (Avon) /ID# 218023
COMPLETED
Avon
Investigators Research Group, LLC /ID# 222891
RECRUITING
Brownsburg
Women's Health Advantage /ID# 246580
COMPLETED
Fort Wayne
Kansas
GTC Research /ID# 217051
RECRUITING
Shawnee Mission
Alliance for Multispecialty Research (AMR) - Wichita West /ID# 218040
COMPLETED
Wichita
Cypress Medical Research Ctr /ID# 217093
COMPLETED
Wichita
Louisiana
Clinical Trials Management - Metairie /ID# 217054
COMPLETED
Covington
Clinical Trials Management, LLC - Covington /ID# 217291
RECRUITING
Covington
Horizon Research Group /ID# 217100
COMPLETED
Eunice
Praetorian Pharmaceutical Research /ID# 217159
RECRUITING
Marrero
Southern Clinical Research A /ID# 218028
ACTIVE_NOT_RECRUITING
Metairie
Women's Health Clinic /ID# 217205
COMPLETED
Shreveport
Massachusetts
Exordia Medical Research, Inc /ID# 217116
RECRUITING
Fall River
NECCR Fall River LLC /ID# 217108
COMPLETED
Fall River
Maryland
SBL Special Services LLC /ID# 224899
COMPLETED
Frederick
Congressional OBGYN /ID# 245349
COMPLETED
Rockville
Continental Clinical Solutions /ID# 217053
RECRUITING
Towson
Michigan
Great Lakes Research Group - Bay City /ID# 217099
COMPLETED
Bay City
Wayne State University, C.S. Mott Center /ID# 248422
RECRUITING
Detroit
Saginaw Valley Med Res Group /ID# 217296
COMPLETED
Saginaw
Missouri
Center for Reproductive Medicine and Robotic Surgery /ID# 223494
COMPLETED
St Louis
Montana
Boeson Research - Great Falls /ID# 248560
RECRUITING
Great Falls
Boeson Research - Missoula /ID# 248559
RECRUITING
Missoula
North Carolina
Duplicate_PMG Research of Charlotte /ID# 217224
COMPLETED
Charlotte
Tyron Medical Partners, PLLC /ID# 245286
RECRUITING
Charlotte
Carolina Women's Research and Wellness Center /ID# 217133
RECRUITING
Durham
Eastern Carolina Women's Centr /ID# 222358
COMPLETED
New Bern
Accellacare Wilmington /ID# 217097
COMPLETED
Wilmington
Carolina Medical Trials - Winston-Salem /ID# 223002
COMPLETED
Winston-salem
Unified Women's Clinical Resea /ID# 217132
COMPLETED
Winston-salem
Unified Women's Clinical Resea /ID# 218339
COMPLETED
Winston-salem
Nebraska
Womens Clinic of Lincoln, P.C. /ID# 217136
COMPLETED
Lincoln
New Jersey
Cooper University Hospital /ID# 227208
COMPLETED
Camden
Jersey Shore University Medical Center /ID# 217138
COMPLETED
Neptune City
Rutgers Robert Wood Johnson /ID# 246933
COMPLETED
New Brunswick
Nevada
Private practice: Dr. Rex G. Mabey JR /ID# 217134
COMPLETED
Las Vegas
Dr. Nader and Associates M.D. P.C. /ID# 223571
COMPLETED
North Las Vegas
New York
Maimonides Medical Center /ID# 248493
RECRUITING
Brooklyn
Invision Health /ID# 218687
COMPLETED
Buffalo
Widewaters Gynecology /ID# 225621
RECRUITING
East Syracuse
Columbia Univ Medical Center /ID# 217113
RECRUITING
New York
New York Presbyterian Hospital Weill Cornell Medical Center /ID# 224329
COMPLETED
New York
Parkmed NYC /ID# 224333
COMPLETED
New York
Richmond OB/GYN Associates PC /ID# 224833
RECRUITING
Staten Island
Ohio
Clinical Inquest Center Ltd /ID# 217961
COMPLETED
Beavercreek
Neuro-Behavioral Clinical Research, Inc. /ID# 224026
COMPLETED
Canton
Duplicate_Duplicate_University Of Cincinnati Medical Center /ID# 217349
COMPLETED
Cincinnati
Seven Hills Clinical Research Group /ID# 224941
RECRUITING
Cincinnati
MetroHealth Medical Center /ID# 224392
COMPLETED
Cleveland
Central Ohio Clinical Research /ID# 217059
COMPLETED
Columbus
HWC Women's Research Center /ID# 246619
COMPLETED
Englewood
Wright State Physicians Health Center /ID# 217272
RECRUITING
Fairborn
Marion Ob/Gyn Inc. /ID# 244175
COMPLETED
Marion
Univ Hosp Landerbrook /ID# 217065
COMPLETED
Mayfield Heights
AC Clinical Research /ID# 227356
COMPLETED
Tiffin
Pennsylvania
Grube Gynecology /ID# 245132
COMPLETED
Frackville
Penn State University and Milton S. Hershey Medical Center /ID# 217057
RECRUITING
Hershey
University of Pennsylvania /ID# 217243
RECRUITING
Philadelphia
reading Hospital /ID# 223599
COMPLETED
Wyomissing
South Carolina
Vista Clinical Research /ID# 217151
COMPLETED
Columbia
University Medical Group /ID# 217355
RECRUITING
Greenville
Vitalink Research - Greenville /ID# 217075
COMPLETED
Greenville
Duplicate_Palmetto Clinical Research /ID# 217069
COMPLETED
Summerville
Biocentric Healthcare Research /ID# 248582
RECRUITING
West Columbia
Tennessee
Chattanooga Research and Medicine /ID# 217045
RECRUITING
Chattanooga
Research Memphis Associates, LLC /ID# 218022
COMPLETED
Memphis
Access Clinical Trials, Inc. /ID# 217055
RECRUITING
Nashville
Texas
Cedar Health Research /ID# 224407
RECRUITING
Dallas
DCT - HCWC, LLC dba Discovery Clinical Trials /ID# 217095
RECRUITING
Dallas
Duplicate_The University of Texas Southwestern Medical Center /ID# 217048
COMPLETED
Dallas
Signature Gyn Services /ID# 217299
COMPLETED
Fort Worth
Progressive Women's Health /ID# 248402
COMPLETED
Friendswood
Willowbend Health and Wellness - Frisco /ID# 217354
COMPLETED
Frisco
FMC Science, LLC - OB/GYN - Georgetown /ID# 218654
COMPLETED
Georgetown
Centex Studies, Inc. - Houston /ID# 217357
COMPLETED
Houston
OBGYN Medical Center Associates - Medical Center Office /ID# 245346
RECRUITING
Houston
UTHealth Women's Research Program - Memorial City /ID# 217362
RECRUITING
Houston
FMC Science /ID# 217047
COMPLETED
Lampasas
Maximos OB/GYN /ID# 229385
COMPLETED
League City
Advances in Health, Inc. /ID# 217220
RECRUITING
Pearland
Clinical Trials of Texas, Inc /ID# 217039
COMPLETED
San Antonio
Discovery Clinical Trials-San Antonio /ID# 218547
RECRUITING
San Antonio
VIP Trials /ID# 217261
COMPLETED
San Antonio
Center of Reproductive Medicine /ID# 217241
COMPLETED
Webster
Utah
Corner Canyon Obstetrics and G /ID# 217289
COMPLETED
Draper
Duplicate_Physicians Research Options /ID# 217302
COMPLETED
Pleasant Grove
Highland Clinical Research /ID# 224052
RECRUITING
Salt Lake City
Virginia
Health Research of Hampton Roads, Inc. (HRHR) /ID# 217063
COMPLETED
Newport News
Clinical Research Partners /ID# 217359
RECRUITING
North Chesterfield
Virginia Women's Health Associates /ID# 227677
RECRUITING
Reston
Clinical Research Partners LLC - Richmond Forest Ave /ID# 217149
COMPLETED
Richmond
Clinical Trials Virginia, Inc. /ID# 217222
COMPLETED
Richmond
Tidewater Clinical Research /ID# 217152
RECRUITING
Virginia Beach
Washington
Seattle Clinical Research Center /ID# 217117
COMPLETED
Seattle
North Spokane Women's Health /ID# 217356
COMPLETED
Spokane
Other Locations
Puerto Rico
Advanced Medical Concepts. PSC /ID# 221337
COMPLETED
Cidra
Henry A. Rodriguez Ginorio, MD /ID# 217233
COMPLETED
San Juan
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 217235
COMPLETED
San Juan
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2020-08-10
Estimated Completion Date: 2030-06
Participants
Target number of participants: 800
Treatments
Placebo_comparator: Double-Blind: Placebo
Participants will receive double-blind placebo on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC (combined oral contraceptive) for 15 months. Participants will be followed-up for up to 12 months.
Experimental: Double-Blind: Elagolix
Participants will receive double-blind Elagolix on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC (combined oral contraceptive) for 15 months. Participants will be followed-up for up to 12 months.
Experimental: Double-Blind: Elagolix + COC
Participants will receive double-blind elagolix in combination with COC (combined oral contraceptive) on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC for 15 months. Participants will be followed-up for up to 12 months.
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov